BEUDAMED
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    ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    V.A.C. FREEDOM THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021

    Graft Integration

    FDA UDI
    Nuvasive, Inc.·00887517244048·Graft Containment Base, TL Tray

    Humeris Shoulder

    FDA UDI
    FX SOLUTIONS·03701037300756·DOUBLE TAPER TA6V +3 mm +/-3°

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707008958·CALIBRA 1ST MOLAR BANDS n.UR 33

    3 Lead Integrated ECG Cable (AngioNew® V & VI)

    FDA UDI
    VASOMEDICAL, INC.·00817980020870·3 Lead Integrated ECG Cable (AngioNew® V & VI)

    COMBITRANS MONITORING SETS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAXISTAT PVA FOAM EMBOLIZATION PARTICLES

    FDA 510(k)
    FDA Class 2 ·Neurology

    1.8MM TI LOCKING SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWP·May 20, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 25, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 26, 2011

    8015 ALARIS SYSTEM PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·June 11, 2021

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·December 26, 2012

    ALARIS PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 2, 2020

    STRYKER

    FDA Adverse Event
    Malfunction ·STRYKER CORPORATION·Product code GEI·January 25, 2023

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code HBL·November 5, 2012

    ALARIS SYSTEM PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 26, 2020

    ALARIS SYSTEM PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 13, 2020

    ALARIS PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·August 28, 2020

    ALARIS PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 24, 2021